Rifadin Oral

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

RIFADIN® ORAL
 
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.
 

Why am I taking Rifadin?

Rifadin contains the active ingredient rifampicin. Rifadin is an antiobiotic taken with other medicines to treat tuberculosis and is taken to treat leprosy.It is also taken to prevent meningococcal disease and infections caused by Haemophilus Influenza Type B.
For more information, see Section 1. Why am I taking Rifadin? in the full CMI.

What should I know before I take Rifadin?

Do not take Rifadin if you have ever had an allergic reaction to Rifadin or any of the ingredients listed at the end of the CMI.
Do not take Rifadin if you have jaundice.
Do not take Rifadin if you are taking saquinavir or ritonavir.These are medicines used to treat AIDS and HIV.
Talk to your doctor if you have any other medical conditions, take any other medicines,or are pregnant or plan to become pregnant or are breastfeeding or planning to breastfeed.
For more information, see Section 2. What should I know before I take Rifadin? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with Rifadin and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

How do I take Rifadin?

Follow the instructions provided when Rifadin was prescribed, including the number of days it should be taken.
More instructions can be found in Section 4. How do I take Rifadin? in the full CMI

What should I know while taking Rifadin?

Things you should do
Remind any doctor, dentist, surgeon, or pharmacist you visit that you are taking Rifadin.
You should see your doctor monthly for a check-up.
Continue taking Rifadin exactly as prescribed by your doctor.
If you have a blood or urine test, tell your doctor you are taking Rifadin.
If you are about to be started on a new medicine, including oral contraceptives, tell your doctor you are taking Rifadin.
Things you should not do
Do not stop taking this medicine because you feel better.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Rifadin affects you.
Looking after your medicine
Store below 25°C.
Store Rifadin in a cool dry place away from moisture, heat or sunlight.
For more information, see Section 5. What should I know while taking Rifadin? in the full CMI.

Are there any side effects?

Side effects include, heartburn, upset stomach, wind, cramps, drowsiness, fatigue, muscle weakness, numbness.
Serious side effects include allergic reactions, severe bleeding or bruising, severe diarrhoea and severe stomach cramps.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Active ingredient(s): rifampicin (rif-am-pee-cin)
Consumer Medicine Information (CMI)
This leaflet provides important information about taking Rifadin. You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about taking Rifadin.
Where to find information in this leaflet:
1. Why am I taking Rifadin?
2. What should I know before I take Rifadon?
3. What if I am taking other medicines?
4. How do I take Rifadin?
5. What should I know while taking Rifadin?
6. Are there any side effects?
7. Product details

Why am I taking Rifadin?

Rifadin contains the active ingredient rifampicin. Rifadin is an antibiotic which kills certain types of bacteria that can cause serious infections.
Rifadin is taken with other medicines to treat tuberculosis and is taken to treatleprosy. Rifadin is also taken to prevent the following diseases:
Meningococcal disease that can cause meningitis.
Infections caused by the bacteria, Haemophilus Influenzae Type B. Despite the name,it is not related to influenza (‘the flu’).Symptoms of this infection can includemeningitis, pneumonia, or conjunctivitis.

What should I know before I take Rifadin?

Warnings

Do not take Rifadin if:

you are allergic to rifampicin or other similar antibiotics such as rifabutin or rifaximin.
you are allergic to any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you are taking saquinavir/ritonavir.These medicines are used to treat acquired immune deficiency syndrome (AIDS) and human immunodeficiency virus (HIV) infections.
you have jaundice (yellowing of the eyes and skin)
you are breastfeeding or planning to breastfeed

Check with your doctor if you:

have any other medical conditions
have any problems with your liver including liver disease
have a problem with bleeding or a tendency to bruise easily
have diabetes
are taking other antibiotics
wear soft contact lenses.Urine, faeces, saliva, sputum, sweat, tears and teeth may be coloured red-orange, yellow or brown by Rifadin.Soft contact lenses may be permanently stained.
are taking any medicines for any other condition
are taking oral contraceptives.You should change to an alternative method of birth control.
have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Do not take Rifadin with saquinavir and ritonavir.These medicines are used to treat acquired immune deficiency syndrome (AIDS) and human immunodeficiency virus (HIV) infections.
Rifadin should not be taken with the following medicines:
halothane, a general anaesthetic (a sleep inducing medicine)
medicines used to treat Hepatitis C (antiviral agents), such as daclatasvir, simeprevir, sofosbuvir and telaprevir
Cephalosporin antibiotics, such as cefazolin used to treat infection
oral contraceptives
Rifadin and some medicines may interfere with each other and affect how they work,such as:
antacids
atovaquone
isoniazid
p-aminosalicylic acid (PAS)
medicines for the treatment or prevention of breast cancer
medicines used to treat thyroid deficiency
medicines for nocturnal cramps
medicines for breathing difficulties
medicines to treat diabetes
medicines to treat nausea or vomiting
Heart or blood-related
medicines that thin the blood, such as clopidogrel
medicines to lower cholesterol
medicines for treating heart problems
medicines for treating high blood pressure, such as enalapril
Infections or immune system-related
medicines to treat bacterial or fungal infections, such as antibiotics or ketoconazole
medicines to treat tuberculosis or leprosy
medicines for treating human immunodeficiency virus (HIV)
medicines to treat malaria
medicines to treat inflammatory conditions
medicines used to keep the body from rejecting transplanted organs
Mental health, brain or pain-related
medicines to treat mental illnesses, such as anxiety or depression
medicines used to control or prevent seizures
medicines that can cause sedation
medicines for pain
Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements you are taking and if these affect Rifadin.

How do I take Rifadin?

How much to take

Follow the instructions provided when Rifadin was prescribed, including the number of days it should be taken.
Swallow Rifadin capsules whole with a glass of water.
If you need to take an antacid, take it at least 1 hour after your dose of Rifadin.

When to take Rifadin

Rifadin capsules or syrup should be taken on an empty stomach at least 30 minutes before or 2 hours after a meal.

If you forget to take Rifadin

Rifadin should be taken regularly at the same time each day. If you miss your dose at the usual time, take the dose as soon as you remember, and then resume taking Rifadin as directed.
If it is almost time for your next dose, skip the dose you missed and take your nextdose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are unsure about taking the next dose, speak to your doctor or pharmacist.

If you take too much Rifadin

If you think that you have taken too much Rifadin, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26 in Australia), or
(by calling 0800 764 766 in New Zealand), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much Rifadin you may experience nausea, vomiting, stomach pain, itching, headache, tiredness, dizziness, swelling, fast or uneven heartbeat or other problems with heartbeating.

What should I know while taking Rifadin?

Things you should do

You should see your doctor monthly for a check-up.Your doctor may order blood tests from time-to-time to check your progress or check for any side effects.
Continue taking Rifadin exactly as prescribed by your doctor
If you have a blood test or urine test, tell your doctor you are taking Rifadin.Rifadin may affect the results of some blood and urine tests.
If you are about to be started on a new medicine, including oral contraceptives, tell your doctor that you are taking Rifadin

Call your doctor straight away if you:

become or intend to become pregnant
are breastfeeding or intend to breastfeed
are about to start taking any new medicine
Remind any doctor, surgeon, dentist or pharmacist you visit that you are using Rifadin.

Things you should not do

Do not stop taking this medicine because you feel better.If you do not complete the full treatment your infection may not completely clear or may return.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Rifadinaffects you.
Rifadin may cause dizziness, drowsiness or other undesirable effects in some people

Looking after your medicine

Store below 25°C
Follow the instructions in the carton on how to take care of your medicine properly.
Store Rifadin in a cool dry place away from moisture, heat or sunlight; for example:
do not store it in the bathroom or near a sink, or
do not store it in the car or on window sills.
Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to take this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not take this medicine after the expiry date.

Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects
What to do
drowsiness
fatigue
difficulty in concentrating
confusion
mental problems
problems with your period
urine, faeces, saliva, sputum, sweat, tears and teeth may be coloured red-orange, yellow or brown by Rifadin. Soft contact lenses may be permanently stained.
Skin or eye-related:
yellow discolouration of skin or eyes
conjunctivitis
problems with your eyesight
Thrush-related:
white, furry, sore tongue and mouth. These are signs of oral thrush.
sore and itchy vagina with or without discharge. These are signs of vaginal thrush.
Muscle or nerve-related:
poor coordination
muscle weakness
pain in the fingers or toes
numbness
 
Stomach or gut-related:
heartburn
loss of appetite
nausea
vomiting
upset stomach
gut discomfort
wind
cramps
diarrhoea. Do not take any diarrhoea medicine without first checking with your doctor.
Speak to your doctor if you have any of these less serious side effects and they worryyou.
 
 

Serious side effects

Serious side effects
What to do
severe red and/or itchy skin, blisters or pimples, bleeding, peeling or bruising of the skin
itching, weakness, loss of appetite, nausea, vomiting, stomach or gut pain, yellowing of the eyes or skin or dark urine
blood in the urine or any other urination disturbances
severe bleeding or bruising more easily than normal
shortness of breath and wheezing
fever, chills, headache or dizziness
bone pain.
develop itching with swelling or skin rash or difficulty breathing, or if you turn yellow.
Allergy-related:
swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing
Call your doctor straight away, or go straight to the Emergency Department at yournearest hospital if you notice any of these serious side effects.
severe stomach cramps or gut cramps
watery and severe diarrhoea, which may also be bloody.Do not take any diarrhoea medicine without first checking with your doctor.
fever, in combination with one or both above.
Tell your doctor immediately if you notice any of these serious side effects, particularlyif they occur several weeks after stopping treatment with Rifadin.
These are rare but serious side effects. You may have a rare serious condition affectingyour bowel, which may need urgent medical attention.
Tell your doctor or pharmacist if you notice anything else that may be making youfeel unwell.
Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stoptaking any of your medicines.

Product details

This medicine is only available with a doctor’s prescription.

What Rifadin capsules contains

Active ingredient
(main ingredient)
150 mg or 300 mg of rifampicin per capsule
Other ingredients
(inactive ingredients)
maize starch
magnesium stearate
The capsule shell also contains
titanium dioxide
erythrosine
indigo carmine
gelatin
Potential allergens
sulfur dioxide

What Rifadin syrup contains

Active ingredient
(main ingredient)
100 mg of rifampicin per 5 mL of syrup
Other ingredients
(inactive ingredients)
agar
sucrose
methyl hydroxybenzoate
propyl hydroxybenzoate
potassium sorbate
saccharin
sodium metabisulfite
polysorbate 80
Raspberry Aroma 15 D 90
diethanolamine
purified water
Potential allergens
methyl hydroxybenzoate
propyl hydroxybenzoate
potassium sorbate
sodium metabisulfite
saccharin
Do not take this medicine if you are allergic to any of these ingredients.
Diabetics should note that Rifadin syrup contains 2 g of sugar per 5 mL of syrup.
Rifadin preparations do not contain azo dyes.

What Rifadin looks like

Rifadin 150 mg capsules have a blue cap and red body each marked “R-150”.They come in packs of 100 capsules (Aust R 233442).
Rifadin 300 mg capsules are opaque red and marked “R-300”.They come in packs of 100 capsules (Aust R 233443).
Rifadin 100 mg per 5 mL syrup is a red liquid supplied in 60 mL bottles (Aust R 10113).

Who distributes Rifadin

Rifadin is supplied in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Rifadin is supplied in New Zealand by:
sanofi-aventis new zealand limited
Level 8, 56 Cawley Street
Ellerslie
Auckland
This leaflet was prepared in Aug 2020.
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